Methods and systems for managing informed consent processes

ABSTRACT

The systems and methods provide a dynamic process for obtaining and managing informed consent documentation. In general, the dynamic informed consent process (DICP) makes use of an intermediary organization, e.g., a trusted intermediary, which: (a) provides ICFs which have been dynamically generated for a specified trial or medical procedure and based on particular state or federal requirements, if any; and (b) archives copies of signed ICFs. In certain preferred embodiments, there may also be a procedure to provide training materials, such as audio or video presentations, to be viewed by prospective participants. In certain preferred embodiments, the process also includes contacting subjects who have signed ICFs in the event that there is a change of circumstance which the subject may deem material to whether s/he would continue to consent, or whether the participant needs to provide a different type of consent to participate in particular event or trial.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/438,677, filed May 22, 2006, which is a continuation of U.S.application Ser. No. 10/122,711, filed Apr. 15, 2002, which claims thebenefit of U.S. Provisional Application No. 60/283,809, filed Apr. 13,2001 and relates to U.S. application Ser. No. 09/939,200 filed: Aug. 24,2001, the entire contents of each application being herein incorporatedby reference.

BACKGROUND OF THE INVENTION

Sequencing of the human genome will generate an avalanche of geneticinformation to be linked with information about microbial, chemical, andphysical exposures; nutrition, metabolism, lifestyle behaviors, andmedications. Advances in DNA sequencing technology and in theunderstanding of the human genome are ushering in a new era of genomicmedicine, one with dramatic potential to not only benefit societythrough research involving human subjects, but also to cause economic orpsychosocial harms to clinical subjects and their families. While insome cases such information may be beneficial to research subjects andtheir families, there is also potential for misinterpretation or misuse.

In today's medical environment, a health practitioner or clinical trialsponsor would (or at least should) never consider performing a medicalprocedure, such as a surgical or diagnostic procedure, on a patient, orputting that individual in a clinical trial, without first obtaininginformed consent. This is not only important from a risk managementperspective, but is basic to the proper practice of medicine.

Special concerns have arisen about the process of informed consent,particularly when the risks and benefits of research participation maynot be fully known. Concerns have also arisen about how best to preventthe preliminary or premature release of research results and to protectthe privacy of individuals who choose to participate in geneticsresearch. Current guidance and protections need to be enhanced to dealwith the special considerations related to genetics research.

The information most often provided in obtaining consent to participatein clinical trial includes the research procedure; the purposes, risks,and anticipated benefits; alternative procedures (where therapy isinvolved); and a statement offering the opportunity to ask questions andto withdraw from the research at any time. Federal regulations (45CFR46and 10CFR745) require the disclosure of a number of issues in anyinformed consent document. They include such issues as potentialbenefits of the research, potential risks to the donor, control andownership of donated material, long-term retention of donated materialfor future use, and the procedures that will be followed. In addition,there are several other disclosures that are of special importance fordonors of DNA for large-scale sequencing. These include:

-   -   The meaning of privacy and confidentiality of information in the        context of large-scale DNA sequencing, and how these issues will        be addressed;    -   The lack of opportunity for the donor to later withdraw the        libraries made from his/her DNA or his/her DNA sequence        information from public use;    -   The absence of opportunity for information of clinical        relevance, e.g., information regarding susceptibility to        disease, etc., to be provided to the donor or her/his family;    -   The possibility of unforeseen risks; and    -   The possible extension of risk to family members of the donor or        to any group or community of interest (e.g., gender, race,        ethnicity) to which a donor might belong.

Comprehension, the manner and context in which information is received,is also another important issue in dealing with informed consent. Manyof the standard informed consent forms currently used have often fatalpractical limitations and they may be inconsistently applied. Typicallythe forms are modified for each specific medical, dental or psychiatricprocedure. While this is efficient, it rarely takes into account theimpacts of the differing information to be conveyed, the differingmanners in which it must be delivered (if read), and the differingattitudes of the patient. Each of these naturally affect thedependability of the form. In addition, as each doctor tries to alter ageneral form for a specific procedure, personal biases can detract fromthe real goal of the process. Even if each of these limitations wererecognized, until the present invention, it simply would not have beenpractical to tailor a document not only doctor to doctor, but also fromday to day, and from patient mood to patient mood. This latteraspect—that a given patient might have different needs from day to dayor hour to hour—has been an aspect that, until the present invention,those skilled in the art could not readily address. Those skilled in theart, the doctors and lawyers, simply believed it was not possible toaccommodate the needs of the patient to this degree. While the need forcontrolled consistency in this area has been openly sought by consumerprotection groups, medical groups, and malpractice insurance carriers,until the present invention it was not deemed practical to attempt toutilize a technique which could be varied to suit each specificoccasion.

Systems and methods that address these issues and develop guidelines andframeworks for ensuring the safe and appropriate use of geneticinformation are crucial to the success of large use of geneticinformation are described below.

SUMMARY OF THE INVENTION

The systems and methods described herein include, inter alai, systemsthat allow a person to control the use of their medical and biologicaldata on a continuous, selective and dynamic manner. Specifically, thesystems described herein include systems that allow a person to store orhave stored into a database their medical and biological data. Alongwith the medical and biological data, the person stores a grant ofconsent that indicates the types of activities and uses to which theperson agrees or consents. The database links the stored data with thegranted consent. As it can be difficult for a person to understand whatkind of consent should be granted, in one embodiment, the system helpsthe person determine what grant of consent to provide. To this end, thesystem can guide the person through a process that helps the personcomplete a consent form that indicates the different allowed uses forthe data. In a preferred embodiment, each grant of consent includes anindication as to whether the person is willing to be re-contacted at alater to date, wherein the re-contact is typically for the purpose ofrequesting the person to consent to a new treatment or use of theirmedical, genetic, demographic or biological data. The grant of consentmay be stored in a database along with and in association with themedical, genetic, and/or biological data.

The systems further include a query mechanism that an interested party,such as a researcher, medical professional or some other person may useto query the stored data to identify individuals of interest. In oneexample, a researcher conducting a study to determine the efficacy of aparticular treatment or regime, searches through the data to identifyindividuals that may have a medical condition, a medical history, agenetic marker or some other condition or conditions of interest to theresearcher. The query, when completed, provides a list of human subjectsthat meet the criteria. To protect privacy, the actual identities of thehuman subjects may be kept secret. In one practice, each person that hasprovided data receives a client code that may be employed to distinguishthat person from the others that have stored data in the system.Optionally, the code may also be employed to re-contact the person.However, the code by itself lacks information that may be employed toidentify the person.

As can be seen from the above, the systems and methods described hereinallow, among other things, a medical professional to identify personsthat may benefit from taking part in a research study and to anonymouslyre-contact the identified persons with a request that they consent tothe required use of their medical and biological data.

In particular, in one aspect the invention provides processes forobtaining informed consent from a human subject for an action or aprocedure. The human subject may be any person that can give consent foran action or procedure. Thus it can be the participant themselves, aswell as a guardian, parent, or court appointed agency. The action thatmay be consented to can be any action or procedure, such as for examplea surgical procedure or a research study. Further, consent may beprovided to allow the system of individuals The process for obtainingthe informed consent may include having the human subject stored datathat is representative of medical and genetic information into a datamemory and having the human subject indicate a grant of informed consentto be associated with the stored data. The process may then allow thequerying of the stored data to determine the grant of informed consentassociated with that stored data, and the allow the determination ofwhether the provided grant of consent is sufficient for the action andincludes a grant of consent to recontact the human subject. The processmay then allow, in response to the determined grant of consent, there-contacting of the human subject to request the human subject tochange the associated grant of informed consent. Typically the requestis that the human subject change the associated grant of informedconsent to a grant of consent that is appropriate, or required, for anaction or procedure that is being proposed by the interested party.

In further embodiments, the process may include having a trusted thirdparty control access to the stored medical and genetic data. The trustedthird party may also broker correspondence between the interestedparties and the human subject, thus providing greater security thatinterested parties will not determine the identity of the human subjectsthat have provided data. Thus in certain practices, the processes allowfor contacting the human subjects by having a trusted third partycontact the human subjects.

To further provide for privacy and anonymity, the processes may allowfor encrypting the data, or portions of the data, that is stored in thedata memory. In this process, the human subject may be allowed to storeportions of the medical and genetic data as clear text and otherportions in an encrypted format. Optionally, the human subjects mayfurther be able to control which portions of the stored data may besearched by an interested party and which portions of the stored dataare to remain private. In further practices, the human subject mayfurther designate controls over what types of interested parties maylook at certain portions of the stored data. Thus, the human subject mayallow certain types of interested parties, such as academic researchers,to view all the stored data while other types of interested parties,such as pharmaceutical companies, may be provided more limited access tothe stored data. In either case however, data that is encrypted forstorage, in some embodiments, may be made available in clear text formatto the query mechanism to allow for searching on encrypted data. Thus,in certain embodiments, the human subject encrypts data stored withinthe data memory for the purpose of protecting that data while it isstored. However, during queries run by interested parties, the processesmay allow the interested parties to search on encrypted data, typicallyby decrypting the data during the data query process, so that this datamay be viewed by the interested parties that the human subject hasauthorized to view that data.

In a further practice, the process will allow storing medical andbiological data as well as contact data that may be employed forrecontacting the human subject. The contact data may be an address, suchas an email address, a post address, a patient code assigned to thehuman subject, an address for the human subject's physician and/or anytype of identity information that may be employed for identifying thehuman subject. The method for contacting the human subject may varyaccording to the application and may include, email, telephone, postmail, and, in a preferred embodiment, by posting messages on a portal,typically a web-based network portal, that the human subject isauthorized to access.

In a typical practice, the processes described herein are capable ofhandling data for a plurality of human subjects. Thus a plurality ofhuman subjects may store data within the data memory. The data in thedata memory may be made available to authorized interested parties forthe purposes of identifying human subjects that may benefit from anaction or procedure being carried out by the interested party. Thus,interested parties may employ the processes described herein fordetermining which of the human subjects that have stored data within adata memory have data that meets certain criteria set out in the query.The processes may return the grant of consent that had been earlierprovided by the human subjects. The process allows for contacting theidentified human subjects with a request to change the granted level ofconsent.

Optionally, the process may contact the identified human subjects, thusproviding the interested party with a platform for identifying andcontacting human subjects that may benefit from participating in anaction, procedure or study. When contacting the human subjects thatprocess may provide to the human subjects information that isrepresentative of the required grant of consent that that human subjectswill need to agree to in order to participate in the action orprocedure. The processes therefore will allow the human subject tochange consent stored in the data memory. In the processes describedherein the human subject may change the consent stored in the datamemory in response to a request to change the consent, or, optionally,at their own volition and unprompted. The human subject can change theconsent data in any manner that they choose, including expanding thegranted level of access and rights to the stored data, reducing thegranted level of access and rights, and eliminating altogether theability to access or use the data. Additionally, the user can expand,restrict, or eliminate the types of parties that are authorized to querythe data that they have stored, or to recontact them. For example, thehuman subject may restrict access to data to only trustedintermediaries. Thus it will be understood to those of ordinary skill inthe art that the systems and methods described herein provide a platformthat offers the human subject a substantial amount of flexibility incontrolling how their data is used and who can use it.

In a further aspect, the invention will be understood to provide systemsfor managing access to medical record and genetic information of anindividual and to allow a researcher or clinician or other biomedicalprofessional to find participants for a study. The systems may comprisea database that has storage for medical record an biological data of anindividual and that has storage for consent data that is representativeof a limited grant of informed consent provided by the individual forthe data. The database can link the consent data with the stored medicalrecord and biological data. The systems further comprise a query toolthat allows a researcher to query the medical record data to identify anindividual of interest to the study and that returns to the researcherthe consent data that is associated with medical record data thatmatches the query. The system further includes a contact mechanism thatcan be a computer process, and that allows the biomedical professionalto indicate a required grant of consent for the study and to contact theindividual and request the individual to grant the necessary informedconsent. The system further includes a response process that allows theindividual to participant in the study by granting the new consent andassociating the new consent with the data provided by the individual.

Optionally, the systems may include data storage for biological sampledata, medical data and genetic data. Storage systems for physicalstorage devices may be incorporated into the systems as well. Thus, insome embodiments refrigeration storage systems for storing samples, suchas tissue samples, may be integrated into the systems described herein.In one embodiment, access to the sample storage systems may becontrolled as well as monitored by the systems described herein. To thisend, these systems may include access control devices that verify accessrequests against a stored level of informed consent provided by thehuman subject. The systems may further include a network web server forproviding access over a data network. In these embodiments, a web servermay be included to provide a portal that gives network access to bothresearchers and individuals. The portal may a secure website thatrequires a password and user name to log on to and access. Thus theportal may provide a secure mechanism for allowing authorizedindividuals to have easy access to the system for the purpose ofmanaging how their data is to be used. At the same time, the web servermay be employed as a portal to present information to authorized user.Thus a biomedical professional may be interested in conducting a studyand, through querying the stored data, may have identified a group ofindividuals that may benefit from the study. The biomedicalprofessionals may generate a description of the study and the benefitsthat it may hold. At the same time the biomedical professionals maycreate an appropriate informed consent form. The biomedicalprofessionals may deliver to the system the description of the study andthe required informed consent form and the system may post thedescription and informed consent form to each of the individualsidentified by the biomedical researcher. Thus in one embodiment, when anauthorized user logs on to the portal, they will be presented with a webpage that describes a study from which the database query indicates thatthey may benefit. The web page may further include a link to therequired informed consent. At the discretion of the individual, theindividual may agree to join the study by granting the required level ofconsent and having the required level of consent be associated withtheir stored data. Optionally, the portal may identify the targetedindividuals that have granted the required level of request and providethis information to the researcher. In this way, the systems and methodsdescribed herein provide a facile system for allowing a biomedicalprofessional to enroll participants into a study or procedure that theyare conducting.

DESCRIPTION OF THE FIGURES

The foregoing and other objects and advantages of the invention will beappreciated more fully from the following further description thereof,with reference to the accompanying drawings wherein;

FIG. 1 depicts a first embodiment of a system according to theinvention.

FIG. 2A depicts a process of compiling together study-specific (i) ICFs,and (ii) genetic education.

FIG. 2B depicts a process of compiling together study-specific (i) ICFs,and (ii) genetic education.

FIG. 3 depicts a process of enrolling participants in a clinical study.

FIGS. 4A and 4B depicts a process whereby a study participant may managesome portion of his or her Informed Consent forms.

FIG. 5 depicts a process for sample handling and collection.

FIG. 6 depicts a process for managing sample genotype data.

FIG. 7 depicts a process for managing the entry of phenotypic data forstudy participants.

FIG. 8 illustrates an exemplary embodiment of the subject system for usein managing the informed consent processes of a genetic trial.

FIG. 9 depicts a process for managing requests for on-line and off-lineeducational materials.

FIG. 10 depicts a process for providing a participant with an ICF forsignature.

FIGS. 11A-C depict a process for a participant withdrawing from a study.

FIG. 12 depicts a process for managing hard copies of executed ICFs.

FIG. 13 depicts a process for controlling access to new samplemanagement protocols.

DESCRIPTION OF CERTAIN ILLUSTRATED EMBODIMENTS

Federal and international regulations demand that all individualsparticipating in clinical procedures, clinical trials or other medicalstudies sign a formal document, known as the “Informed Consent Form”(ICF). These documents must be signed after the individuals havereceived (by their physicians as well as by other study-relatededucation specialists) sufficient information to have a reasonableunderstanding of the non-technical study aspects (e.g., scope, risks,future use of results, future use of the personal and medicalinformation provided by the study participant, etc.). The ICF is toprovide a succinct description of these aspects. After signed by anindividual, an ICF constitutes formal evidence of the willful andinformed decision of the individual to be part of the study. Typically,although optionally before a study participant at a given site can signan ICF, an Institutional Review Board (IRB) or Ethics Review Board (ERB)at that site is to approve the study protocol and the ICF.

Obtaining informed consent specifically for the purpose of donating DNAfor large-scale sequencing may raise some unique concerns. Becauseanonymity typically cannot be guaranteed and confidentiality protectionsare not absolute, the disclosure process to potential donors shouldclearly specify what the process of DNA donation involves, what may makeit different from other types of research, and what the implications areof one's DNA sequence information being a public scientific resource.

The systems and methods described herein provide a dynamic process forobtaining and managing informed consent documentation. In general,although not in all embodiments and practices, the dynamic informedconsent process (DICP) makes use of an intermediary organization, e.g.,a trusted intermediary, which: (a) provides ICFs which may have beendynamically generated for a specified trial or medical procedure andbased on relevant study, state and federal requirements, if any; and (b)archives copies of signed ICFs. In certain embodiments, the processesprovide training materials, such as written, audio or videopresentations, to be reviewed by prospective participants. In certainembodiments, the process also includes contacting subjects who havesigned ICFs in the event that there is a change of circumstance whichthe subject may deem material to whether s/he would continue to consent,or to recontact participants with a proposal to join another study or tocontinue with a study as it progresses to a later stage.

An often common complication to any of the above examples of instanceswhich are suitable for use of the subject process is that, because oflocal regulatory differences among geographic locales, ICFs are to betailored to the study participant's location (state, country) as well aspotentially having to be translated in the participant's nativelanguage. To this end, and as described later, the subject systems andprocesses may be used to generate ICFs which account for such localvariations in requirement.

Once created, the subject informed consent process may also be used tomanage ICFs for clinical trials. For instance, the systems and processesmay be used to deliver information and obtain verification from aprospective participant that s/he understands that the trial is ascientific experiment and there may be risks and dangers to their healthand privacy that s/he has been told about the reasons for doing thetrial, the identity of the drugs which may be given, the number ofvisits and the kinds of lab tests required. Additionally and optionally,as different and various types of data may be stored, generated oremployed as part of the clinical trial or procedure, including thegenotypic data, demographic data, identity data, medical history dataand other types of biological data, the ICF is likely to speak to theentities and purposes that are allowed to employ this data. Thus, incertain embodiments, the systems and methods described herein may beused to manage the ICFs for human subjects providing access to genotypicor other individually identifiable phenotypic information, which may bean outcome of, for example, a clinical trial, a diagnostic test, or ahealthcare database. Likewise, the subject method can be used to managethe ICFs for subjects providing tissue or cells samples for research ordiagnostic purposes or for use in a cellular product.

In many instances of clinical trials or genetic testing, ICFs arestudy-specific and cannot be modified. In these cases, if a new study,Study B, has to be designed to expand on a previous genetic study, StudyA (e.g., because new findings indicate that it makes sense to pursue adifferent avenue), then a new protocol must be generated and approvedand a new ICF must be generated and signed by all the studyparticipants. Thus, Study A participants are to be re-contacted to asktheir permission to use the material collected during Study A for thenew Study B. In the case of the subject invention re-contacting ispossible, either directly or, in some embodiments, through a trustedintermediary, as the systems and methods described herein have a linkbetween study participants, their data and, in some cases, theiridentity. Thus, re-contacting is possible using the systems and methodsof the invention.

In still other embodiments, the systems and methods described hereinmake it possible to dynamically generate ICFs. Thus, the subject systemsand methods may be used by a healthcare provider to advise patients ofcurrent alternatives, e.g., it updates the ICF to include anydevelopments in management and treatment that would be beneficial ordetrimental or that could cause them to choose another course of action.The subject methods and systems can also be part of a patient managementmethod which includes recontacting former patients when new developmentsoccur. The term “duty to recontact” refers to the possible ethicaland/or legal obligation of medical or genetic service providers torecontact or attempt to recontact former patients about advances inresearch that might be relevant to them. Patients' knowledge of advancesin the molecular genetic bases of their disorders may have great impacton their lives, affecting their psychological well being, reproductiveoptions, employment decisions, and lifestyle choices such as marriage;in addition, there is a consensus in the medical genetics community thatpatients should have access to information about such advances. Suchrecontact of patients may be triggered in the systems and methodsdescribed herein upon the occurrence of such situations as (1) those inwhich a diagnosis had been suspected, but not made, and a new diagnostictest has been developed; (2) those in which a more accurate diagnosticand/or prognostic test, postnatal or prenatal, has been developed (e.g.,from linkage to mutation detection); and (3) those in which newinformation may alter the prognosis or recurrence-risk estimates.

From the perspective of a bio-medical professional the systems andmethods described herein provide tools that allow for easily identifyinghuman subjects that may be appropriate for a study or action and forcontacting these subject with the requests for the required consent. Theinvention therefore can also be seen as tools that make it easier for abio-medical professional to organize a study or other action.

The invention, in its various embodiments, recognizes and addressesthese and other problems and overcomes many limitations encountered bythose skilled in the art by bringing together, and bridging the gapsthat have existed between the legal, medical, consumer and trainingfields with respect to establishing dynamic, certifiable informedconsent.

Those skilled in the art will appreciate that the subject processes andsystems can, but need not, be carried out in a fully or semi-automatedmanner, e.g., utilizing computer systems to generate the ICFs, archivethe executed ICFs, and prompt for recontact of a subject when necessary.For ease of reading, the following description of exemplary embodimentsis directed to the utilization of computerized systems for at leastcertain aspects of the subject process.

II. Exemplary Embodiment

FIG. 1 depicts a first embodiment of the system according to theinvention. Specifically, FIG. 1 depicts a system 10 that allows aplurality of human subjects to control, optionally dynamically, theconsent that they grant for the use and access of their medical, geneticand biological data. Additionally, as well be explained in more detailbelow, the system 10 depicted in FIG. 1 provides a platform that allowsa biomedical professional to easily enroll participants into a study orother action. The system 10 depicted in FIG. 1 will now be explained inthe context of a system that allows individuals to control dynamicallythe consent they grant over their data during a process in which theindividuals decide whether to enroll within a study being offered by abiomedical professional. However, although FIG. 1 is merelyrepresentative of one embodiment of the invention, an embodiment thatintegrates a plurality of components into a single system. It will beapparent to those of skill in the art that a single integrated system isnot required and that the different components of the system may be keptseparate from each other and operate a different locations withcommunication occurring over a data network or through some othermethods.

In the embodiment of FIG. 1, the system 10 contemplates a singleintegrated system of the type that may be maintained and operated by atrusted third party. A trusted third party could include a company,government agency organization or other entity or entities that arefamiliar with the different relevant legislative frameworks that controland regulate the distribution of medical data, identity data, geneticdata, and other types of controlled data. Typically, the trusted thirdparty would be an entity that is also familiar with the rules andregulations that control and regulate the requesting and granting ofinformed consent. However, it will be apparent to those of skill in theart that the systems and methods described herein may be employed inother contexts, including contexts wherein there is no trusted thirdparty and the entity that is carrying out the enrollment process is thebiomedical professional themselves, or an organization supporting thebiomedical professionals, such as a pharmaceutical corporation, ahospital, or some other type of entity. However, for the purpose ofclarity the system 10 will now be described within the context of anenrollment process that employs a trusted third party for brokering theexchange of a request for consent and the delivery of consent betweenbiomedical professionals and individuals that have stored their data ina data repository.

More particularly, FIG. 1 depicts a system 10 that includes a queryprocess 12, a database 14, a recontact process 18, a portal process 20,a consent process 22, an enrollment request 24, a list of enrolledparticipants 28 and a query 30. In a typical embodiment, the differentprocesses and the database 14 may be realized as a data processingsystem comprising a computer program and a computer server on which thatprogram is executing. Accordingly, each of the processes 12, 18, 20 and22 depicted in FIG. 1 may represent a single computer program that isrunning on a computer server. Similarly, the depicted database 14 mayrepresent a database management system computer program and anon-volatile storage device or other type of data memory capable ofproviding long term storage of data. The query process 12 may be a SQLquery process of the type commonly employed for performing queries ofdata stored within a database system.

More specifically, the depicted database 14 may be any suitable databasesystem, including the commercially available Microsoft Access Database,and can be a local or distributed database system. In this embodiment,where a trusted intermediary is employed, the database 14 may be part ofa genetic banking system, such as the ENTRUST genetic banking systemprovided by First Genetic Trust of Chicago Ill. Such a genetic bankingsystem can provide secure storage of a person's demographic, medical,genetic, and biological data. As well as other information the personchooses to store. As is described in the above referenced U.S.application Ser. No.: 09/939,200, Filed: Aug. 24, 2001, titled METHODFOR INDEXING AND STORING GENETIC DATA, the database 14 may provide forsecure storage of data such that patient identity information is storedseparately from patient medical data. As described in the referencedapplication, each person storing data in the database may be providedwith a virtual private identity (VPI) code that links the patient totheir identity information. This identity information may kept in asecure and encrypted database. The VPI may also be used as a key into asecond separate database that contains inter alai, medical, genetic,biological and sample data. Thus the VPI can act as a link between aperson's identity data and their medical data. By controlling the VPI sothat it can only be used by a entity authorized by the person (typicallyby requiring the person to provide a private key to be used with theVPI) the database 14 can allow access to the patient's medical, geneticand biological data, without allowing access to the patient's identityinformation.

Although the database systems described in the above-identifiedreference may be employed with the system 10, it will be understood thatother database systems may be employed as well. The design anddevelopment of suitable database systems are described in McGovern etal., A Guide To Sybase and SQL Server, Addison-Wesley (1993), thecontents of which are incorporated by reference. The database 14 can besupported by any suitable persistent data memory, such as a hard diskdrive, RAID system, tape drive system, floppy diskette, or any othersuitable system. The system depicted in FIG. 1 includes a databasedevice 14 that is integrated with the system 10. However, it will beunderstood by those of ordinary skill in the art that in otherembodiments the database device 14 can be separate from and evenremotely located from the system 10.

In either case, the system 10 includes within the database 14 a storagelocation for storing information that is representative of the grant ofconsent provided by a person. This grant of consent typically includes agrant of informed consent that indicates the type of access and usesthat may be made of the person's information. Additionally, the consentdata typically includes a field to indicate whether the person hasconsented to being re-contacted. Further and optionally, the grant ofconsent may include data representative of restrictions put on the useof the data by the person, where these restrictions or consents relateto whether interested parties, such as researchers, clinicians,pharmaceuticals companies, or others, can search their data or contactthe person. Similarly, the consent may include a restriction on themanner in which a person may be re-contacted. For example, the personmay require all contacts to be made by a trusted third party, and mayrequire that the contact by sent by e-mail to the person's physician.Thus, it can be seen that the system 10 of the invention now providesthe genetic baking system with consent information that may be storedwith the person's medical, genetic and other data and that may indicatecontrols, permissions and restrictions placed on the data by the user.

How the medical data and consent data get stored or organized within thedatabase 14 will depend upon the application and any suitable techniquemay be employed. The organization of data within the database system 14will, typically, involve a set of tables and fields that will organizethe data into searchable units. This table and field structure isdescribed in the above-cited McGovern reference.

With consent data now stored in the database 14, a query process, suchas the query process 14 may be provided that checks with the consentdata when performing searches for a bio-medical professional—or anintermediary acting at the request of a bio-medical professional. Thequery process 12 can generate queries that act on the tables and fieldsof the database 14 for the purpose of being able to sort through datathat is stored in the database 14. The query process 12 also organizesdata into search results that will be returned as the response to thequery 30. Accordingly, an authorized biomedical professional that mayhave logged onto the system 10 via a secure Internet session may submita query 30 to the query process 12, and the query process 12 can analyzethat query 30 and create an SQL compliant demand that may be understoodby the database 14. In a typical example, the query 30 submitted by thebiomedical professional will be a request to search through the datatables of database 14 to identify medical, biological, genetic orphenotype data having certain characteristics.

The query 30 may include other parameters as well including demographicparameters and medical history parameters. In any case, the query 30submitted by the biomedical professional will be processed by the queryprocess 12. The query process 12 will determine a set of SQL commandsthat may be used to identify the set of data that satisfies theparameters outlined within the query 30. The depicted query process 12will also review the consent data associated with any information thatmeets the parameters of the search query 30. To this end, in oneembodiment, the query process 12 develops SQL commands that retrievefrom the database 14 a set of identifiers that represent individualsthat have stored data relevant to the query 30. The identifiers areoften anonymous in that they themselves lack identifyinginformation—such as the VPIs described above. The identifiers arereturned for persons that have stored data that meet the requirements ofthe query 30. The query process 12 can then review the identifiedconsent data and determine which of the individuals have provided anassociated grant of consent with their data that indicates consent to bere-contacted. The re-contact consent is often for the purpose ofreceiving requests to change the grant of consent they earlier provided.The query process 12 may then forward to the recontact process 18 thelist of individuals that meet the parameters set up in the query 30 andthat have agreed to be re-contacted.

As described above, the type of restrictions, permission and accesscontrols provided by the person within their consent data may varyaccording to the application. Consequently, the query process 12 mayperform other operations. For example, in those applications wherepeople are allowed to restrict whether their data or portions of theirdata can be searched, the query process 12 may perform an initialprocess that identifies which data records or portions of data recordsstored in database 14 may be processed. In other embodiments, wherepeople are allowed to restrict what types of entities can search theirdata, such as only allowing trusted parties or bio-medical professionalsassociated with research hospitals carrying out studies on a particularform of cancer, the query process 12 may first do an initial sort of thedata records to identify data that is available for searching underthese parameters.

In an optional embodiment, the query process 12, or another process, mayalso include an authorization process that requires a biomedicalprofessional to enter a user name and password into the system. The username and password can associate the biomedical professional with theparticular entity, or type of entity, project, or type of research. Inthis embodiment, the query process 12 can employ information about thebiomedical professional to determine whether the biomedical professionalhas been granted the right to search data within the database 14. Insome embodiments, the database 14 may be subdivided into differentsections, with certain sections of the database being available tobiomedical professionals of a particular type, such as academicresearchers or researchers conducting studies related to a particulartype of cancer. Thus in these embodiments, the query process 12 maylimit the application of query 30 to that data which has been authorizedto be searched by biomedical professionals of the identified type.

In further optional embodiments, the query process 12 may include adecryption process that can decrypt data that has been stored in anencrypted format. For example, in one embodiment all data stored in thedatabase 14 is stored in an encrypted format. The decryption process mayemploy a password based encryption/decryption algorithm that can encryptand decrypt stored data as a function of a password employed by thedatabase 14. Processes for encrypting data can include simple XORalgorithms, one-time pad based algorithms or more complex ciphersincluding any of the algorithms or techniques described in BruceSchneir, Applied Crytpography (Addison-Wesley 1996), the contents ofwhich is herein incorporated by reference. Any of these processes may becarried out by the query process 12, and other process shown in FIG. 1,to allow these process to manipulate in clear text data that has beenstored in an encrypted format.

In either case, the depicted query process 12 can return a list ofindividuals that have medical, genetic and other data that meet theparameters of the query 30 and that have agreed to be re-contacted. Inone embodiment, the query process 12 provides the search results to thebio-medical researcher. The search results in one practice include therelevant medical data and the consent data granted for the medical data.Depending upon the application, the system 10 may default to a processthat requires that each person providing data be re-contacted with arequest to execute a new grant of consent. This is the process that isimplemented by the system 10 of FIG. 1. In an alternate practice, thesystem 10 may allow the bio-medical professional, or some other entityto determine which of the individuals are to be re-contacted. Otherpractices may be employed depending upon the application at hand.

In either case, the re-contact process will be invoked. In the depictedembodiment, the re-contact process 18 responds to the request of thequery process 12 to recontact each of the identified individuals. Tothis end, the recontact process 18 can obtain or generate informationthat may be helpful to an individual that is going to be recontactedwith a request to change their granted consent. In one embodiment, therecontact process 18 requests the biomedical professional to provide abrief description of the purpose of the study or other action beingproposed. Additionally, the recontact process 18, as will be describedin greater detail hereinafter, may require the biomedical professionalto go through an informed consent process that generates, by itself oras part of a larger process, an appropriate and compliant informedconsent form that may be provided to the different individuals that aregoing to be re-contacted. One process for generating such an informedconsent is shown in FIGS. 2A-7.

Once the recontact process 18 has the necessary information to requestthe individuals to consider changing their grant of consent, the process18 can send a request to the portal process 20. In one embodiment, theportal process 20 includes an HTTP compliant server process thatprovides a secure portal that allows individuals storing data indatabase 14 to access an account maintained used by the system 10. Theportal process 20 notifies the individuals of a request for them toconsider joining a study, procedure, or some other activity thatrequires the individual to change the grant of informed consent.

In the depicted embodiment the portal process 20 accesses the database14 for each individual identified by the recontact process 18. For eachindividual, the portal process 20 retrieves from database 14 a patientcode that may be employed for generating an enrollment request page thatwill be served by the portal process 20 to the respective individualwhen that individual next logs onto the portal. Additionally, andoptionally, the portal process 20 may retrieve from the database 14 acontact data record that provides some kind of addressing information sothat the portal process 20 may proactively notify the respectiveindividuals that there is a request for them to consider altering theirgrant of informed consent. In one practice, the portal process 20retrieves contact data that is representative of an email address. Theportal process 20 can then email to the individual a request that theyvisit the secure portal site to view the information that has beengenerated by the recontact process 18 and which will be served by theportal process 20 once the individual accesses the secure portal. Oncethe individual has accessed the portal, the portal process 20 canpresent the enrollment request 24, which may be a typical web page, tothe individual. If the individual so chooses, in this embodiment theymay activate a link provided on the enrollment request page that returnsto the portal process 20 an indication that the individual has agreed tothe change of informed consent. To this end, the portal process 20 canactivate a consent process 22 that updates the granted informed consentinformation stored for that individual within the database 14. Theprocesses for updating the informed consent data record can vary andexamples of such processes are depicted in FIGS. 9-13.

Thus, it will be understood that the portal process 20 can also beunderstood as on example of a consent process that will be employed bythe system for allowing a person to change the grant of consent providedwith their data and stored in the database 14. Other examples of consentprocesses are set out below with reference to FIGS. 9-13.

In depicted embodiment, each time an individual changes their consentwithin the database 14 the recontact process may be notified. If therecontact process 18 determines that the individual changing theirconsent is associated with the list generated by query process 12, therecontact process 18 can indicate that the individual has enrolledwithin the associated study and, optionally after a set period of time,generate a web page 28 of enrolled participants. The web page 28 may beserved over a secure connection to the associated biomedicalprofessional.

Accordingly, FIG. 1 depicts one exemplary system according to theinvention that allows individuals to agree to change the grant ofinformed consent such that the individuals may participate in a study oraction that may be of benefit to them.

In the system 10, each time the biomedical professional wants tore-contact a human subject, the biomedical professional provides thesystem 10 with an informed consent form that the human subject is toreview and execute. The informed consent form (ICF) may be manuallyprepared by the biomedical professional. However, in certain alternativeembodiments, the ICFs are created in an automatic or a semi-automaticway. Typically, every action or study has a number of predefinedassociated sites (in the case of pharmacogenetic trials, the sites arethe participating hospitals). The system 10 can assemble and maintain adatabase of regulation-compliant ICF templates for some or all possiblesites. When the protocol for the study has been finalized, the Managerof the study requests the generation of appropriate ICFs for allparticipating sites. As FIGS. 2A and 2B illustrate, this request canstart an automatic process which:

-   -   1. Generates appropriate ICF templates for every participating        site (e.g., all such sites that have registered on the DICP        system during the process of setting up the study). Appropriate        sections of the templates can be automatically filled by        information extracted from corresponding sections of the study        protocol.    -   2. Notifies the Protocol Manager of the study to fill in those        sections of the ICF templates which were not handled        automatically in the previous step.    -   3. Forward the generated ICFs for internal review and then for        review, comments and IRB-approval to the appropriate contact        persons at the participating sites. The contact persons may get        back to the Protocol Manager with requests for modifications,        made by the IRB at the contact persons' sites.

Particularly, FIGS. 2A and 2B depict pictorially a process for designinga study, such as the study of the efficacy of a cancer drug, as well asa process for developing a protocol design and study management. Thus,FIGS. 2A and 2B describe how a study and protocol may be designed andmanaged and it will be understood that the created study and protocolmay be implemented by employing the systems and methods described hereinincluding the system 10 depicted in FIG. 1.

Turning to FIG. 2A, the major actors involved in study design, powercalculation, protocol design and management are depicted. Specifically,FIG. 2A depicts a study design process 40 wherein a pharmaceuticaltrials manager 42, a clinical statistician 44, a pharmaceutical protocolmanager 46, an internal review board agent 48, and a hospital physician50 come together and cooperate to develop a study. As depicted in FIG.2A, the pharmaceutical trial manager 42 can help determine the type oflab information that will need to be collected and databased for thestudy as well as the different pharmacogenetic information that willhave to be collected and then stored as well. As shown in FIG. 40, thepharmaceutical trial manager 42 can help develop the lab informationdatabase 52 as well as the pharmacogenetic trial database 54. Inpractice, legacy clinical trial databases may be employed to helpsupplement or seed these databases. Information on these databases caninclude trial information from past legacy clinical trials and hospitalcontact information. Other information may be stored in these databases52 to 54 as well.

FIG. 2A further depicts the clinical statistician 44 may contributeinformation to a type of bio-informatic database and may help determinethe type of information that needs to be stored in this database 56.Additionally, the clinical statistician 44 may help design thepharmacogenetic protocol database and master plan tracking database 58that will be employed during the study. As further shown in FIG. 2A, thepharmaceutical protocol manager 46 may aid in the development of thepharmacogenetic protocol database 58 as well. The depicted hospitalphysician 50 may communicate with the pharmaceutical trial manager 42and may provide input to the various databases including thepharmacogenetic database 54 and the pharmacogenetic protocol database58. Additionally, as shown in FIG. 2A, the hospital physician 50 mayparticipate in the protocol approval process along with the internalreview board agent 48. The information collected during the study designcan include information regarding phenotype data management, samplecollection and management, genotyping management, genotype data storageand management, as well as information about the dynamic informedconsent that will be necessary and information that may be employed fordynamic informed consent creation. Thus the database can storeinformation about the required informed consent as well as informationthat can help the system 10, optionally, dynamically generate theinformed consent that will be provided to human subjects.

FIG. 2B depicts pictorially the kinds of information that may,representatively, be employed during the dynamic informed consentcreation process. Specifically, FIG. 2B depicts a process 60 that showsdifferent factors considered during the dynamic informed consentcreation process. These factors can include the type of informationnormally provided by an informed consent form, specific informed consentinformation for the clinical site as well as protocol informed consentinformation for the clinical trial and templates of informed consentforms that comply with state, local, and federal guidelines andregulations. FIG. 2B further depicts that optionally genetic educationmaterial may be provided as part of the dynamic informed consent.Additionally, genetic education material that is relevant to theclinical site as well as the clinical trial protocol and differentstate, local, and federal regulations may also be part of the processthat dynamically generates the informed consent form.

Optionally, other educational material may be assembled together withthe IC form. This can be a content-building process, where both on-lineand off-line educational material for a specific study is compiled.Off-line educational material can include books, videos, CDs etc. As inthe compilation of the IC forms, there are multi-language issues andeducational templates that are specific to individual locales and study.Further, each Human Subject may include with their demographic data apreference of language selection. This preference of language selectionmay be employed by the ICF process to generate a form and selecttemplates written in the selected language. FIG. 9 depicts one processfor providing educational materials to the Human Subject. The languageof the educational materials may similarly be selected according to datastored in association with the person receiving the educationalmaterial.

As shown in FIG. 3B, the enrollment of an individual X in a study can beperformed by an authorized Person Y (usually a Physician participatingin the study). In particular, FIG. 3B depicts a study participantenrollment process 70. In particular, FIG. 3 depicts pictorially that astudy participant may provide demographic information and may completethe necessary informed consent to register for the process. Optionally,a physician 74 may look at the demographic information as well asvarious screening criteria to determine whether the study participantshould be enrolled in the process. The screening criteria as well as thetrial registration process may be performed according to the studydesign and protocol design and management guidelines 76 that weredeveloped during the process 40 depicted in FIG. 2A. FIG. 3 furtherdepicts that the informed consent 78 provided by the study participant72 may be, in some optional embodiments, provided electronically by thestudy participant 72 employing a digital signature to execute thedynamically generated informed consent form. In the process 70 of FIG. 3a virtual private index identification code is provided to the studyparticipant 72. This code may be employed by the study participant toallow the study participant to provide medical, biological, genetic orphenotypic data to the study but do so using the VPI so that providingthe information is done anonymously. The VPI provided to the studyparticipant 72 may be employed by the study participant 72 to monitorthe study and the optionally receive information from the physician 74conducting the study. One technique for generating VPI codes isdescribed in the above referenced U.S. Patent Application entitledMETHOD FOR INDEXING AND STORING GENETIC DATA.

The exemplary enrollment process may involve the following steps:

-   -   1. Screening: the authorized Person Y performing the enrollment        should confirm that the potential Study Participant X meets the        requirements for being part of the study. To do so, Y may log        onto the DICP system and get access to that part of the protocol        of the study that defines the inclusion/exclusion requirements        that study participants are to meet.    -   2. Registration/Certification: If X is not already in the        database, then Y may register X with DICP. This step involves,        for example, entering the personal information of X into the        system, and requesting credentials for X (such as user Id and        password or/and the creation of a digital certificate). The        outcome of this step is to make X a “registered person” in the        DICP system.    -   3. Account Creation/Update: If X has never before participated        in a DICP study, a new Login Account can be created; otherwise,        his or her existing Account is used. The Login Account is        updated with the addition of an entry for the study at hand.        This entry is automatically populated with links to on-line        educational material for the instant study, links to the on-line        informed consent documents, etc.

There are a number of occasions where it may be advantageous to permit aStudy Participant to manage at least a portion of his of her informedconsent process. FIGS. 4A illustrates certain embodiments whereby theStudy Participant participates in managing at least a portion of theprocess involved in complying with informed consent requirements for astudy.

In general, before participation in a study begins, a Study Participantmust sign the appropriate ICF or ICFs for the study, e.g., afterreceiving the appropriate study-specific education/counseling. In theillustrated embodiments, at the time of the Participant's enrollment,on-line educational material and on-line ICFs are linked to theParticipant's Account (as part of the Account entry created for thestudy at hand). In such embodiments, the subject system may include aneducational material system that allows an account holder (or anauthorized user typically a study participant or prospectiveparticipant) to gain access to educational material both on-line as wellas by physical delivery of offline educational materials for any of thestudies he is participating in. The physical delivery can be, e.g., bymail or may be outsourced to a third party vendor. In certainembodiments Study Participants (or authorized Proxies) may also be ableto access on-line or off-line counseling through their account, such asgenetic counseling.

Accordingly, FIG. 5 depicts pictorially a process 100 wherein a studyparticipant that is provided by an identity code, in this case, avirtual private identity (VPI) code, provides biological, genetic, orsome other sample data to the study. The process 100 provides a samplecollection and management protocol process that allows samples to becollected, temporarily stored, and shipped. The protocol furtherprovides for sample receiving and storage, sample processing, sampletracking, and DNA and protein shipping. The different steps in thesample collection and management can be carried out in accordance withthe protocol. The set up for these processes is set out by the protocolregistration. In the process 100 depicted in FIG. 5 the studyparticipant may give informed consent to the use of their sample data.However, once the data has been sampled and stored and information aboutthat sample has been stored in the database 14, the data are, ifauthorized, available to consider for use in subsequent studies.Accordingly, the system 10 depicted in FIG. 1 provides a DICP systemthat a biomedical professional may employ for contacting enrolledparticipants and distributing to them new informed consent forms thatfollow the guidelines and requirements set up for the proposed study andprovide the necessary level of consent or grant of consent to conductthe study. Thus, in this example, samples that were originally wereprovided by the study participant for one particular sample ofprocessing procedure may subsequently be of interest to a biomedicalprofessional for another study. In this situation, the study participant102 may be recontacted by the DICP system 10 with a new informed consentform and a request that the study participant 102 execute that form sothat the storage sample may be employed.

Whether the ICF is generated dynamically or not, the ICF is deliveredand signing of the ICF can be performed either on-line or off-line. AsFIG. 12 shows, in certain embodiments, the Participant can print out acopy of the ICF, sign the document, and return the signed document tothe DICP system 10. In certain preferred embodiments, an image of atleast the signature page(s) is captured and the audit trail for thatParticipant is updated. To facilitate tracking of such documents, a barcode can be generated on the documents at the time they are printed.Upon imaging the documents, the bar code can than be used to link theimage, or an OCR thereof, with the Account Holder.

In certain instances, a study participant may decide to withdraw from astudy and request that all the samples taken from him or her in thecontext of that study be destroyed and all information connecting theParticipant to the study erased from DICP system 10. This functionallows study participants enrolled in a pharmacogenetic study, as anillustration, to withdraw from the study and request the destruction ofall the samples and data taken from him or her in the context of thisstudy. Because study participants may withdraw at various points of astudy, there are different dependencies and actions that may occur.Also, the fact that a user withdrawing from one study does not mean heor she is withdrawing from all studies or withdrawing from the DICPsystem 10. FIGS. 11A, B and C show an exemplary mechanism by which thesystem can achieve such a withdrawal.

After the study participant has indicated withdrawal from a particularstudy, the system 10 operates as an ICF manager that may confirm thatthe participant does indeed want to withdraw. Upon confirmation, the ICFmanager will initiate the steps of withdrawal, which optionally includesdestruction of the patient's samples and information related to thespecific study.

The system 10 has been described as part of an enrollment process foridentifying and enrolling human subjects into a study, action orprocedure. However, the system 10 may also be seen to provide a systemthat dynamically creates and/or distributes ICF forms for participantsregistered with the system 10. Such a dynamic system, that can determinewhether there is authorization/consent provided to recontact the humansubject and, if authorized, recontact the human subject to get a newgrant of informed consent, may be employed in many other applications.For example, FIG. 5 illustrates a sample collection and managementprotocol. In certain embodiments, the subject DICP 10 system may includea component which provides centralized management, tracking, andauditing of samples obtained from Study Participants, e.g., tissue orcells samples, nucleic acid sequences or the like, and the protocolsapplied to them. In many instances, such samples may be stored atremote, third-party sample labs. In such instances, the subject DICPsystem 10 can be used to track operations and events relative to eachsample.

Thus will be seen from the above description that the systems andmethods described herein include systems that can optionally dynamicallygenerate an informed consent form that may be employed by the system 10to enroll a human subject as a participant in a study, action, or otherprocedure. This process, as described above and as depicted in FIG. 4B,may be realized as a computer program operating on a computer server. Asshown in FIG. 4B, the process may include a first step 90 wherein aprotocol and study are developed. As described above the development ofthe protocol and study may be done according to conventional processesthat consider the information that needs to be collected before thestudy, the type of patients that need to be enrolled in the study, thetypes of protocol that need to be in place for managing information,data, samples, and other elements of the study and review proceduresthat are to be followed while conducting the study, working with humansubjects, and during later data analysis.

As shown in FIG. 4B the process may then move to step 92 wherein theprocess 90 may create an informed consent form. In step 92 the process90 may create a template that includes in the template the kind ofinformation that is to be provided to a subject to satisfy informedconsent requirements set out by the clinical site, the clinical trialprotocol, state, local and federal regulations, and any other criteriathat need to be considered under the developed protocol and study.Optionally, the template generated may be an XML form that may includeidentified fields that contain information that is to be presented tothe human subject and fields that are to completed by the human subject.Fields provided by the human subject may include fields that indicatethe type of informed consent being provided by the human subject. Forexample, the informed consent form may be an XML page that may includefields that may be included by the human subject to indicate whether ornot they are willing to be recontacted, what type of researcher,clinician, or entity may recontact them, whether their information anddata stored within the database 14 may be viewed, queried, or otherwiseemployed by interested parties conducting different kinds of research.What kinds of studies they are willing to be contacted about, forexample studies related to treatment of cancer, infertility, aids, orsome other kind of study.

After step 92 the process may proceed to optional step 94. In optionalstep 94 the process may create educational materials such as educationalmaterials about genetic education, the disease being treated, or someother relevant educational material. The educational material selectedmay be chosen to comply with the study protocol and design and to complywith educational requirements set out by the clinical site, the clinicaltrial protocol, or vary state, local or federal regulations. Other typesof educational material may also be provided as part of the informedconsent procedure.

After step 94 the process proceeds to step 96. Step 96 is an optionalprocess wherein language translations of the informed consent forms maybe generated. Thus informed consent forms may be translated form Spanishto English, from English to Japanese, or into some other language thatmay relevant to the pool of perspective participants. The translation ofthe forms may occur in part or in whole by automatic translationprocesses. Such automatic translation processes are known in the art andany suitable automatic translation process may be practice with theinvention described herein. In particular, automatic translationprocesses may be employed for processing headings, titles, andinstructions that appear within the informed consent form. Optionally,the content provided on the form may be translated by a human translatorand entered into the database separately.

When translations are created the process may proceed to step 98 whereinthe developed informed consent form is tested against the protocolsearlier designed and developed. This step may be an interim step thatforwards the generated form to a internal review board or other relevantauthority that reviews the form for compliance with the protocols,regulations, and objectives earlier set out. Once the form is approvedthe process may proceed to step 99 wherein the approved informed consentform is provided to the system 10 depicted in FIG. 1 for subsequentdelivery to the appropriate human subjects.

In preferred embodiments, the system 10 is understood as a DCIP systemthat can also provide support for all the steps that comprise the lifecycle of a sample. For instance, the DICP system 10 can be used to tracksample acquisition. For instance, to take a sample, an appropriate“sampling protocol” will often be followed. The sampling protocol (e.g.,which is part of the study protocol) describes such steps andrequirements as (i) how much sample needs to be taken, (ii) how thesample taken needs to be aliquoted (e.g., how many sub-samples should beobtained from the master sample), (iii) procedures for temporary storageof the sample, (iv) procedures for shipping the sample to its finalstorage destination, etc. When visiting a sampling facility, a StudyParticipant uses DICP-issued credentials to instruct the samplingfacility of the sampling protocol that must be used for thatParticipant.

To further illustrate, storing a sample may require following theappropriate “sample storage protocol” which defines sample pre-storagehandling procedures and appropriate storage conditions (the storageprotocol is also part of the larger, study protocol). This protocol ismade available to the sample storage facility. For tracking purposes, asample can be bar-coded or otherwise marked with a study-related SampleId (SID) as well as with a Sample Lab Id (SLID). SIDs are defined in thestudy protocol and are the means of identifying samples for studypurposes. SLIDs are examples of a mechanism that the sample storagefacility can use for tracking inventory. In the illustrated example, thelink between SID and SLID must be made known to the DICP system 10, inorder to allow for appropriate sample tracking.

Samples can be retrieved for a number of reasons, e.g., in order to besent to a genotyping lab for further processing or in order to bedestroyed as the result of a Study Participant's decision to withdrawfrom the study. In such cases, the procedure to be followed for theretrieval is described as part of the study protocol and should be madeavailable to the sample storage facility.

In certain embodiments, the DICP system 10 compiles and maintains adatabase of “Sampling Labs” and “Sample Storage Labs”. Every entry inthis database contains information about the capabilities of that Lab,e.g., which sampling/storage protocols that facility supports. See, forexample, FIG. 13. The contents of this database can allow thedesigner(s) of a study to make educated selection of the sites that willparticipate in the study, based on the availability of close-by Labsthat can support the needs of the study.

FIGS. 6 and 7 depict further processes that may benefit from the systemsand methods described herein. In particular, FIGS. 6 and 7 depictrespectively a process 110 for genotyping management and a process 120for phenotype acquisition and management.

FIG. 6 illustrates an exemplary embodiment of a genotyping managementprotocol for the subject DICP system 10. Genotyping of samples willoften take place in genotyping labs. Upon the initiation of a genotypingrequest, the appropriate samples are retrieved from their correspondingsample storage facility and shipped to the genotyping lab. Upon receipt,the genotyping lab is to proceed by following the “genotyping protocol”which is part of the study protocol and defines the sequence of actionsto be performed. The genotyping lab gets access to the appropriategenotyping protocol through the barcodes (or numeric ids) on thereceived samples. The results of genotyping process are reported back tothe DICP system 10, after going through a “format conversion” component,if necessary, that translates them to the appropriate DICP-compliantdata format. Similar to the Sampling Lab case described above, the DICPsystem 10 can compile and maintain a database of genotyping labs.

In certain embodiments, the subject DICP system 10 will include aPhenotype Acquisition & Management protocol. As illustrated in FIG. 7,such a sub-system allows the entry of phenotypic data for the StudyParticipants. The type of data to follow and report, are defined in thestudy protocol. The collection of all that data can be considered the“study-specific medical record” (SSMR) of the Study Participant. TheDICP system 10 can provide a “Universal Medical Record Model” (UMRM),e.g., in accordance with existing standards, which can describe variousphenotypic traits. For each trait, the UMRM can contain information like(i) the trait name (e.g. “Blood Pressure”), (ii) the associated valuetype (e.g., “numeric”), (iii) permissible ranges (E.g., “Positive, lessthan 40”), etc. The SSMR can be defined (on a study basis) as theappropriate subset of the UMRM.

Updating the SSMR of a Study Participant, is typically only allowed tobe done by authorized Persons (e.g. a physician) that have appropriateProxy rights on the Study Participant's account.

FIG. 8 illustrates an exemplary embodiment of the subject system for usein managing the informed consent processes of a genetic trial and wherethere is a DICP supported phenotypic database 146 and a DICP supportedgenotypic database 148. These databases 146 and 148 may be generatedaccording to the processes described with reference to FIGS. 6 and 7. Itwill be apparent to those of skill in the art that a DICP supportedsample database may also be provided, as well as databases containingother types of data. Thus, in the embodiment of FIG. 8 it can be seenthat different components of a computer supported study or action mayinclude or use the DICP systems described herein. In this embodiment,the informed consent 142 is linked, via the trusted intermediary, withgenotypic and/or phenotypic data derived for the patient. In the processof obtaining the consent of the patient to the use of such data, certainembodiments of the subject system 140 can be set up to obtain varyinglevels of consent from the patient, e.g., which may effect to whomaccess is given and how a certain portion of the patient's data may beused. For instance, the DCIP system 140 can provide a controlledinterface to the databases for bioinformatics analysis. Thebioinformatics tools 150 can be provided as part of the DCIP system 140,or can be that of a third party on whose behalf consent for suchanalysis has been obtained from the patient. Such components/interfacesof the system 140 can provide advanced tools and algorithms foranalyzing and correlating genotypic and phenotypic data.

The invention now being generally described, it will be more readilyunderstood by reference to the following examples which are includedmerely for purposes of illustration of certain aspects and embodimentsof the present invention, and are not intended to limit the invention.

EXAMPLE 1 Receiving and Signing of Informed Consent Form A. Use CaseDiagram

This use case allows the study participant to access the InformedConsent Form (ICF) and Questionnaire online or by postal mail.

Study participant receives the ICF and Questionnaire by mail if desired.He must sign and mail the ICF and questionnaire back to DICP. This canbe done online by pressing “I Accept” button and filling thequestionnaire online.

A notification for signing an ICF for a particular study is posted inthe message box of the Study participant's page on the portal.

For the ICF to be valid, it has to returned and signed before itsexpiration date.

While requesting ICF by postal mail, study participant can specify if hewants to receive educational material along with ICF.

Questionnaire is optional and part of the ICF. Filling the questionnaireis not mandatory.

B. Basic Flow

Participant Action System Response 1. Potential Participant 2. Systemdisplays a pending request logs into the Study for signing the InformedConsent Form Participant portal. along with the ICF expiration date forthe study he's participating in. 3. Participant clicks 4. Systemdisplays a screen with three on the notification message options: forsigning ICF. a. Generate a printable ICF b. Receive ICF by Mail c. SignOn-line When actor selects any of the above options a barcode specificto the actor and study for which he is signing ICF is generated by thesystem. This barcode along with it's corresponding human readable numberwill appear on the top of all the pages of ICF and questionnaire.

C. Generating a Printable ICF

Participant Action System Response Participant selects System generatesa read-only PDF file of “Generate Printable the ICF and questionnairewhich can be ICF” downloaded and printed. System also displays messageexplaining downloading and configuration instructions for Acrobat Readerfor reading and printing PDF files. System is notified that an ICF hasbeen printed and ICF responding workflow is invoked. Scavenger willcheck on all ICF's that have not been received yet. The generated PDFfile also has the return address of DICP where the form needs to besubmitted. Participant displays the PDF file generated in the Step 2.Participant can print the file or save it on his local system for laterprinting. After signing the ICF he mails it to the DICP.

D. Receiving ICF/Educational Material by Mail

Participant Action System Response Participant selects System retrievesthe mailing address from “Receive ICF by the actor's record and displaysfor Mail” option in the confirmation. Participant has an option step 4.to edit the mailing address. This address is not updated in his systemrecord. System checks if this is first time, Participant is given anoption of receiving the educational material along with ICF. Participanthas a System checks for the validity of the choice of saying, addressspecified by the Participant. If “Yes” to receiving incorrect, acorresponding error message offline educational is displayed with anoption to update. material. Presses the Otherwise a request to thirdparty vendor “Submit” button. for mailing the ICF form/Educationalmaterial (if relevant) is triggered. Participant receives theICF/Questionnaire and Educational material by mail. Participant fills inthe questionnaire signs ICF and mails it back to DICP.

E. Signing ICF On-line

Participant Action System Response Participant selects System displaysthe questionnaire, which “Sign On-line” needs to be filled by theParticipant. Questionnaire is optional component of ICF. Participantoptionally System displays the ICF form with the fills in thequestionnaire “I Agree” and “I Don't Agree” and presses submit button.buttons. Participant presses the System displays confirmation box and if“I Agree” button. actor accepts that an acknowledgement page isdisplayed. The corresponding “Acceptance” workflow is triggered.Participant presses the System displays confirmation box and if “I Don'tAgree” button. actor confirms to disagree an appropriate message isdisplayed. The “Dissent” workflow is triggered.F. Alternate Flow: System has Returned an Invalid Address MessageAgainst what the Actor Entered

Participant Action System Response System will generate a message to theactor that the address they have entered does not match with the addresson file

G. Alternate Flow: Participant Requests Only ICF by Mail

Participant Action System Response Participant edits the System checksfor the validity of the address and presses the address specified by theactor. If “Submit” button. incorrect, a corresponding error message isdisplayed with an option to update. Otherwise a request to third partyvendor for mailing the ICF form Participant receives theICF/Questionnaire by mail. Participant fills in the questionnaire signsICF and mails it back to DICP.

The processes described above pictorially can be engineered as computerprocess running on a computer server. For example, FIG. 9 depicts oneprocess 200 that may be representative of a computer process running ona computer server and being capable of providing educational material toa study participant or prospective study participant. As shown in FIG. 9the process 200 begins a step 202 wherein it proceeds to step 204wherein the actor selects the study and then selects the educationalmaterial that they wish to view or have to view. In step 206 the systemdisplays the materials to the actor and in step 208 the actor selectsadditional desired educational material. The request for material isreviewed in decision block 210 wherein if the information is online theprocess 200 in steps 212 and 214 displays the online information to theactor and the actor can review it and the process can end at step 216.Alternatively, if during decision block 210 it is determined that thematerial is not online, the process 210 can proceed to step 218 and 220.Wherein the offline material is available and can be sent through theprocess beginning at step 222 or the message in step 220 can bebroadcast typically indicating that the information is no longeravailable.

However, if in step 218 the materials are determined to be offline andavailable the process 200 can proceed to decision block 222. In decisionblock 222 the process can determine whether or not the study participanthas already reviewed all the material that they can receive offline, ifyes, they can be told so in step 240. Alternatively, if no, the actormay be provided with three options. These three options are set out indecision blocks 225, 226 and 227. Typically, to maintain anonymity forthe prospective study participant the process can choose to mail theinformation to the physician's address. Alternatively, the subject canchoose to have the information mailed to their own address in a file orcan have the information sent to an alternative address. In either casethe process in step 228 confirms that the mailing address is correct andonce that information is concerned the process proceeds to steps 229,230, 231 and 232 wherein the submission request is reviewed, confirmed,recorded and noted for the purposes of validating the conformed consentprocedure. However, if the step 228 determines that the mailing addressis incorrect then the process provides several steps 234, 235 and 236,wherein the prospective study participant can amend the mailing address.

FIG. 10 depicts a computer process 250 for having an informed consentform be executed, or signed, by the human subject and returned to thesystem. Specifically the process 250 begins with the steps 252, 254, 256and 258 wherein the process determines that the participant needs tosign a informed consent form, allows the participant to navigate to theinformed consent form for the selected study and allows the system tochoose the informed consent form based on the study and location that isrelevant to the participant. If the form is online then in step 260 theprocess transfers the steps 262, 264 and 266 wherein the online form ispresented to the participant. In the depicted process the form isprovided with a “click wrap” agreement that allows the user to executethe agreement by clicking a button “I agree”. In alternative practicesdifferent kinds of execution may be employed such as digital signatures,biometric identity verifications and authorizations and other similartypes of processes.

Once the form is executed the process 250 can record the updated grantof consent and the process may end at step 270. At the decision block260 however, it may be determined that the informed consent formnecessary is not online, in this case the process can proceed to step272 wherein the participant prints out the ICF and the questionnaire andthe system understand that the form has been printed out and the patientin step 276 signs and completes the ICF and the questionnaire and mailsthe ICF and questionnaire back to the biomedical professional, a trustedthird party, or some other identity. In step 280 an offline process maybe employed for entering the form into the database 14 of the system. Asfurther shown in FIG. 10, the process may include a step 282 whereinthere is a requested mailing. If this is the first time that somethinghas been mailed then it may be determined that the documents may bemailed to the human subject. Alternatively, in steps 290, 292 and 294the participant may be prompt to receive a mailing of educationalmaterials. If they accept the educational materials then again theprocess will capture the mailing address and mail off the educationalmaterials along with the informed consent form and the questionnaire tothe participant. In alternative embodiments where educational materialhave to be either sent and/or reviewed by the participant, there may beno option step for the user to only receive the informed consent formand the questionnaire and instead will have to receive the educationalmaterials as well.

FIGS. 11A, 11B and 11C depict processes for allowing a study participantto withdraw from a study, an action, or a procedure. It will beunderstood that the processes depicted in FIGS. 11A through 11C arerepresentative of processes that the invention provides to allow a userto change the grant of consent they have provided. In the processesdescribed hereinafter, the study participant chooses to withdraw oreliminate their grant of consent. However, in other processes the studyparticipant may choose to expand, reduce, or otherwise change the grantof the consent that they had provided. Accordingly, it will beunderstood that the processes described below are merely representativeof the types of processes that may be provided by the invention andvariation to these example processes will be apparent to those withordinary skill in the art.

Turning to FIG. 11A, a process 300 is depicted that begins in a step 302and proceeds to step 304. At step 304 the process 300 determines whetherthe user is logged in. If the user is logged in, the process proceeds tostep 306. At step 306, the system displays a main study participantportal screen. The portal screen may be understood to be a webpageprovided by the system to the user for the purpose of presenting thestudy participant with information that is relevant to the managing ofthe participants talent. The portal may be a web portal of the kindprovided to allow for authorized access to different services andinformation supported by the portal. To this end, in one embodiment, theportal may be realized as a secure web server capable of transferringHTTP compliant data across a data network. The design and development ofsuch portals is known to those with skill in the art and any suitableportal may be practiced with the present invention without departingfrom the scope thereof.

As further shown in FIG. 11A, the study participant may employ theportal in step 308 to navigate to the personal account informationmaintained by that participant. The portal employed in 308 may besimilar to the portal provided by portal process 20 depicted in FIG. 1.In step 310, the system displays the specific studies that theparticipant has registered in. In the particular practice depicted byFIG. 11A, the user is provided a virtual private identity code that maybe employed by the system has an index key into a database that storesinformation associated with that key and therefore that user. Thevirtual private identity key may be kept secret by the user, therebyproviding a level of security to the database that stores informationabout that user. In step 312, the user may select a pharmacogeneticstudy of interest. The system then may display the selectedpharmacogenetic study information and link to the appropriate informedconsent form. In step 318, the user chooses to withdraw from a study.After that, the process can proceed to step 320 wherein the systemdisplays action consequences and confirms the actions of the studyparticipants. If in step 322 the user verifies their request towithdraw, then the process may proceed to process 350 depicted in FIG.11B. Alternatively, if the user chooses not to withdraw, then theprocess may proceed from step 322 to step 314.

However, upon an indication of a request to withdraw, the process 350depicted in FIG. 11B may be invoked. In process 350 the studyparticipant is displayed, in step 352, contact information. At decisionblock 354, the user can verify that contact information and correct itif necessary. In step 356, the system can update an audit trail. Theaudit trail will be representative of the actions taken by the studyparticipant through the portal site. In step 358, the system can assignan action id in a workflow system and in step 360, the system candetermine the appropriate manager of the study and notify him of thewithdrawal. In step 362, the system can display a request that has beensubmitted (and other instructions as well). After step 362, the processmay proceed to process 390 depicted in FIG. 11C. Returning to decisionblock 354, if the user wishes to update their contact information, theprocess at 354 may proceed to step 364. The process in subsequent steps368, 370 and 372 may choose to update and confirm their change of systemaddress information. In decision blocks 374 and 376, the process canrequire a verification step to allow the address change to occur. Ifverified, the address can be changed. If not, the system can cancel theprocess. The saving of the information is depicted in step 382 shown inFIG. 11B.

Turning to FIG. 11C, the process 390 is depicted as showing step 392where it is determined whether the user is logged in. Between 392 and398, the determination is made and the process 390 proceeds to 393. At393, the system displays the main informed consent form manager screen.The process 390 may then proceed to step 394 wherein the system displaysa pending informed consent form. In step 395, the informed consent formmanager can select notification messages from a list and in step 396 thesystem can display the withdrawal request and contact informationprovided from study participant. At step 397, for each pendingunsubscribed action, the informed consent form manager contacts thestudy participant vis a vis a telephone to verify the validity of theaction. If the action is invalid, the process at step 399 proceeds tosteps 400 and 402 wherein the ICF manager removes the unsubscribedaction and amends the audit trail. Alternatively, if the action is notinvalid, and therefore valid, the process proceeds to steps 404, 406,408 and 410 wherein the system activates an unsubscribed process, thatnotifies all related parties of the action, and there is a successfuldestruction of data step 408. In step 410, the system generatesnotification to the participant indicating that they have been withdrawnand that their data has been destroyed.

FIG. 12 depicts a process that the systems and methods described hereinmay employ for receiving a hard copy of the signed informed consent formfrom a prospective study participant. In particular, FIG. 12 depicts aprocess 420 that begins at step 422. The process proceeds to step 424wherein the person, in this case the prospective study participant orstudy participant that is interested in changing, including expanding orreducing the grant of consent that they earlier provided, receives adocument from either the group running the study or from a trustedintermediary. In step 426 the person can execute the document typicallyby signing it and dating it and sends it back to the appropriateauthority. In the process 420 the appropriate authority may be thetrusted intermediary party or may be some other party such as theclinical site where the study participant will give samples or otherinformation.

In step 428 the authorized entity receives the form and in step 430 logsthe form into the system 10. And in step 432 indicates that the form hasbeen entered into the system. The process 420 then proceeds to step 434wherein a representative reviews the documents for signature. Atdecision block 436 the process determines whether the persons signatureis accepted. If it is accepted the process then checks in step 438whether the witness signature is accepted. The option of using a witnessmay be available in some practices of the invention however it is notalways required. If the signatures are accepted the process proceeds tostep 440 wherein an authority scans the document image into the documentdatabase based on a barcode provided with the informed consent form. Atstep 442 the process determines whether consent has been granted. Thisstep can involve verifying other kinds of criteria to consent such ashas the form been completed and returned within the appropriate timeframe, has the form been sent in duplicate, and other kinds of criteria.If the answer is yes then the process 420 can proceed to step 444wherein a representative at the entity activates the document consentrecord and reports questionnaire results if this are required. Theprocess then proceeds to step 446 wherein the system updates the audittrail and workflow. If at the decision block 436 it is determined thatthe persons signature is not accepted then the process may proceed tosteps 448 and 450 wherein a representative reviews the remainder of thedocument for other errors and the representative send the person a newdocument requesting their signature. Optionally, the new form may beaccompanied by a cover letter than outlines the errors that arose in theoriginal document.

Turning now to FIG. 13 a further process that may be employed by thesystem depicted in FIG. 1 is depicted. Specifically, FIG. 13 depicts aprocess 470 that controls the access of new samples being managedaccording to the selected protocol. The process 470 includes a step ofentering the sample management protocol into the system 10 andactivating workflow. At step 474 the sample lab manager may be notifiedthat a new sample management protocol has been put in their queue forreview. The sample lab manager, at step 476 may access the system 10 andbe sent the new sample management protocol into their queue via workflownotification. The sample manager accesses their queue of samplemanagement protocols and in 479 the sample lab manager selects the newsample management protocol to review from the list provided. At step 450the system displays a sample management protocols and in step 452 theuser reviews protocol for visibility and translates the samplemanagement protocol into their internal system.

After step 452 the process may proceed to process 454 wherein the systemprompts the user to confirm that the lab is able to meet therequirements and confirm that the lab is not able to complete therequirement or to identify the fact that they will confirm thisinformation later. At decision block 456 the user validates that the labcan meet the requirements. In step 458 the user inputs commentsregarding their ascent and in steps 460-464 the system records that thesample lab can execute the requested protocol sends a notice to thesystem, if such notice is dictated by business rules and personnel thenattend to offline activity. Alternatively, if act decision block 456 theprocess determines that the lab can not meet the certain requirementsset out the process proceeds to step 468 wherein the user validates thatthe lab can not meet the requirement. If such validation occurs then theprocess in steps 469-472 inputs comments regarding the descent recordsthat the sample can not execute the requested protocol and the systemsends a record to the appropriate personnel if such a notice or recordis dictated by business rules. Alternatively, if at step 468 the usercan not confirm that the requirements can not be met the system proceedsto step 473 wherein they indicate that at a later time the user willselect to ascent or decline.

As discussed above, the dynamic informed consent process and systemsdescribed herein may be realized as a software component or componentsoperating on a conventional data processing system such as a Unixworkstation. In that embodiment, the DCIP system may be implemented as aC language computer program, or a computer program written in any highlevel language including C++, Fortran, Java or basic. Additionally, inan embodiment where microcontrollers or DSPs are employed, the DCIPsystems may be realized as a computer program written in microcode orwritten in a high level language and compiled down to microcode that canbe executed on the platform employed. The development of such systemsfollows from techniques known to those of skill in the art, and suchtechniques are set forth in Digital Signal Processing Applications withthe TMS320 Family, Volumes I, II, and III, Texas Instruments (1990).Additionally, general techniques for high level programming are known,and set forth in, for example, Stephen G. Kochan, Programming in C,Hayden Publishing (1983). It is noted that DSPs are particularly suitedfor implementing mathematical functions, including encryption functions.Developing code for DSP and microcontroller systems follows fromprinciples well known in the art.

Additionally, although FIG. 1 graphically depicts the DCIP systems 10 asan arrangement of interconnected functional block elements, it will beapparent to one of ordinary skill in the art that these elements can berealized as computer programs or portions of computer programs that arecapable of running on a data processor platform to thereby configure thedata processor as a system according to the invention. Moreover,although FIG. 1 depicts the system 10 as an integrated unit, it will beapparent to those of ordinary skill in the art that this is only oneembodiment, and that the invention can be embodied as a group ofcomputer programs that operate on different separate machines, includingmachines located at different physical locations, such as machineslocated at a clinical site and machines located at the site of a trustedintermediary, with the different sites communicating for example acrossa data network such as the Internet.

Accordingly, the systems and methods described above are merelyrepresentative of the different embodiments that may be realized fromthe invention, and other systems and applications may be realized,including for example systems for allowing attorneys to identify memberof a particular class that may have a common cause of action, systemsfor organizing clinical trials, post-marketing surveillance, and patientrecruitment for genetic and genomic research, as well as the delivery ofmolecular diagnostics and therapeutics.

1. A process for obtaining informed consent from a human subject for anaction, comprising having the human subject store data representative ofmedical and genetic information into a data memory, having the humansubject indicate a grant of informed consent to be associated with thestored data, allowing querying the stored data to determine the grant ofinformed consent associated with the stored data, allowing thedetermination whether the provided grant of consent is sufficient forthe action and includes a grant of consent to re-contact the humansubject, and allowing, in response to the determined grant of consent,to contact the human subject to request the human subject to change theassociated grant of informed consent.
 2. A process according to claim 1,further comprising having a trusted third party control access to thestored medical and biological data.
 3. A process according to claim 1,wherein allowing the contacting of the human subject includes having atrusted third party to contact the human subjects.
 4. A processaccording to claim 1 or 2, further including encrypting the medical andgenetic data stored in the data memory.
 5. A process according to claim1, wherein allowing a human subject to store medical and biologicalrecord data includes allowing the human subject to store portions of themedical and biological record data as clear text and portions in anencrypted format
 6. A process according to claim 4, wherein allowingqueries of the stored data includes allowing queries on encryptedmedical and genetic data.
 7. A process according to claim 1, furtherincluding storing with the medical and biological contact data forrecontacting the human subject.
 8. A process according to claim 7,wherein the address is of the type selected from the group consisting ofan e-mail address, a post address, patient code assigned to the humansubject, an address for the human subject's physician, and identityinformation for the human subject patient.
 9. A process according toclaim 1, wherein contacting the human subject to request the humansubject to change the associated grant of informed consent includescontacting the human subject by a method selected from the groupconsisting of e-mail, mail, putting a notice on a bulletin board,contacting the human subject's physician, telephone, and using a portalthe human subject is authorized to access.
 10. A process according toclaim 1, further including providing a form representative of therequired grant of consent
 11. A process according to claim 1, wherein aplurality of human subjects have stored data within the data memory,further comprising determining which of the human subjects identified bythe query require a different grant of consent, and contacting theidentified human subjects with a request to change the granted level ofconsent
 12. A process according to claim 11, wherein contacting theidentified human subjects includes delivering a form for changing thegranted level of consent.
 13. A process according to claim 1, furtherincluding allowing a human subject to change the consent data stored inthe data memory.
 14. A process according to claim 13, wherein changingthe consent data includes any one of expanding the granted level ofaccess, reducing the granted level of access, and eliminating access.15. A process according to claim 1, further comprising posting forreview by the human subject a notice identifying new actions that thehuman subject may want to be part of.
 16. A system for managing accessto medical record and genetic information of an individual to allow abiomedical professional to find participants for a study, comprising adatabase having storage for medical record data of an individual andhaving storage for consent data representative of a limited grant ofinformed consent provided by the individual for the data, a query toolthat allows a researcher to query the medical record data to identify anindividual of interest to the study and that returns to the biomedicalprofessional the consent data associated with medical record andbiological data that matches the query, a re-contact mechanism forallowing the biomedical professional to indicate a required grant ofconsent for the study and to contact the individual and request theindividual to alter the provided grant of informed consent to complywith the required grant of informed consent, and a consent mechanism forallowing the individual to participate in the study by granting a newconsent.
 17. A system according to claim 14, having storage for medicalrecord and biological data representative of previously collectedbiological samples, medical and genetic data.
 18. A system according toclaim 14, having a network web server for providing access over a datanetwork.
 19. A system according to claim 14, further including anencryption mechanism for encrypting the medical record data.
 20. Asystem according to claim 17, wherein the query mechanism includes meansfor performing a query on encrypted data.
 21. A system according toclaim 14, wherein the contact means includes an e-mail process, abulletin board process, and a process for delivering information in anelectronic data folder.
 22. A system according to claim 14, includingenrollment means for receiving communications from individuals anddetermining, as a function of the granted level of consent, whether toenroll the individual in an action or study.
 23. A system according toclaim 14 further comprising a query process having a process for sortingdata records in a database as a function of consent data stored in thedatabase and associated with data records stored therein
 24. A computerreadable medium having stored thereon instructions for implementing aprocess for obtaining informed consent from a human subject for anaction, comprising having the human subject store data representative ofmedical and genetic information into a data memory, having the humansubject indicate a grant of informed consent to be associated with thestored data, allowing querying the stored data to determine the grant ofinformed consent associated with the stored data, allowing thedetermination whether the provided grant of consent is sufficient forthe action and includes a grant of consent to re-contact the humansubject, and allowing, in response to the determined grant of consent,to contact the human subject to request the human subject to change theassociated grant of informed consent.